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Impact of an Optimised Monitored Anesthesia on the Patients' Recovery After Cytoreduction Surgery Plus HIPEC (CHIPNOL)

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ClinicalTrials.gov Identifier: NCT04104334
Recruitment Status : Unknown
Verified September 2019 by Philippe Richebe, Ciusss de L'Est de l'Île de Montréal.
Recruitment status was:  Recruiting
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Philippe Richebe, Ciusss de L'Est de l'Île de Montréal

Brief Summary:
The objective of our PILOT study is to evaluate the impact of a controlled (monitored) randomized anesthesia during cytoreductive surgery with HIPEC to oxaliplatin in order to treat adenocarcinomas of colorectal origin. The combination of NOL monitoring, BIS monitoring and continuous hemodynamic monitoring (FloTrac EV1000 system) can improve patient safety by reducing the length of hospital stay by decreasing total hypnotic doses and intraoperative opioids and side effects following anesthesia.

Condition or disease Intervention/treatment Phase
Hyperthermia Colorectal Neoplasms Oxaliplatin Drug: Remifentanil infusion, desflurane titration and fluid infusion will be guided by NOL index, BIS index and Flotrac EV1000 system respectively Drug: Remifentanil infusion and desflurane titration will be guided by anesthesia usual practices Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 groups of patients. Randomization into Monitored group "M" (BIS + NOL + Flotrac EV1000) vs control group "C" (standard of care anesthesia) according to randomization list for a total number of 80 patients.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Randomization into Monitored group "M" (BIS + NOL + Flotrac EV1000) vs control group "C" (standard of care anesthesia) will be done prior to the entrance in the OR, the day of the surgery.
Primary Purpose: Prevention
Official Title: Evaluation of the Impact of Combined Intraoperative Monitoring of Depth of Analgesia, Depth of Anesthesia and Continuous Hemodynamic Data on the Patients Recovery After Cytoreduction Surgery and Hyperthermic Intraperitoneal Chemotherapy
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : July 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Monitored group "M" (optimized controlled anesthesia)
Patients in the Monitored group "M", the NOL index will guide the administration of remifentanil to keep the index between 5-25, and the desflurane will be titrated to keep a BIS index between 45 and 55. Cardiac output and stroke volume variation will be measured by the Flotrac EV1000 system. Patients will receive 250ml fluid challenges with a recommended solution as required, in order to achieve a maximal value of stroke volume.
Drug: Remifentanil infusion, desflurane titration and fluid infusion will be guided by NOL index, BIS index and Flotrac EV1000 system respectively
NOL index will guide the administration of remifentanil to keep the index between 5-25, and the desflurane will be titrated to keep a BIS index between 45 and 55. Cardiac output and stroke volume variation will be measured by the Flotrac EV1000 system. Patients will receive 250ml fluid challenges with a recommended solution as required, in order to achieve a maximal value of stroke volume
Other Name: Monitoring group

Active Comparator: Control group "C" (standard of care anesthesia)
Patients in the Control group "C" will be managed by clinical staff according to usual practice, desflurane will be administered to keep MAC at 1, and remifentanil infusion rate will be adapted to the mean arterial blood pressure to keep it between 65 and 100.
Drug: Remifentanil infusion and desflurane titration will be guided by anesthesia usual practices
Desflurane will be administered to keep MAC at 1, and remifentanil infusion rate will be adapted to the mean arterial blood pressure to keep it between 65 and 100, according to anesthesia usual practices
Other Name: Control group




Primary Outcome Measures :
  1. The hospital length of stay in days [ Time Frame: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days ]

    The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria.

    These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012).

    After these criteria are achieved, discharge may take place.


  2. Tolerance of oral intake [ Time Frame: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days ]

    The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria.

    These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include:

    - Tolerance of oral intake.

    After these criteria are achieved, discharge may take place.


  3. Recovery of lower gastrointestinal function [ Time Frame: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days ]

    The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria.

    These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include:

    - Recovery of lower gastrointestinal function.

    After these criteria are achieved, discharge may take place.


  4. Adequate pain control with oral analgesia [ Time Frame: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days ]

    The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria.

    These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include:

    - Adequate pain control with oral analgesia.

    After these criteria are achieved, discharge may take place.


  5. Ability to mobilize and self-care [ Time Frame: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days ]

    The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria.

    These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include:

    - Ability to mobilize and self-care.

    After these criteria are achieved, discharge may take place.


  6. Clinical examination and laboratory tests show no evidence of complications or untreated medical problems [ Time Frame: Evaluated 24 hours postoperative and everyday until hospital discharge, up to 21 days ]

    The length of hospital stay in group "M" versus group "C" will be evaluated with the readiness for discharge from hospital criteria.

    These criteria for hospital discharge will be precisely and daily evaluated based on the previous published literature from experts who reached a consensus (J.F. Fiore et al. Disease of the Colon and Rectum, volume 55: 4, 2012) and this will include:

    - Clinical examination and laboratory tests show no evidence of complications or untreated medical problems.

    After these criteria are achieved, discharge may take place.



Secondary Outcome Measures :
  1. Intraoperative anesthetic gas' consumption in ml/kg/h [ Time Frame: Intraoperative ]
    Total consumption and absorption of desflurane in ml/kg/h during surgery and for each hour of surgery

  2. Intraoperative remifentanil consumption in mcg/kg/min [ Time Frame: Intraoperative ]
    Total consumption of i.v. remifentanil during surgery and for each hour of surgery

  3. Intraoperative fluid's consumption in ml/h [ Time Frame: Intraoperative ]
    Total of fluid perfused during surgery and for each hour of surgery

  4. Intraoperative number of hypotensive events [ Time Frame: Intraoperative ]
    Total number of hypotensive events during surgery (defined as mean blood pressure below 60)

  5. Intraoperative phenylephrine consumption in mcg/kg/min [ Time Frame: Intraoperative ]
    Total doses of intraoperative infused i.v. phenylephrine and doses per hour

  6. Intraoperative epidural consumption in 3 ml/h [ Time Frame: Intraoperative ]
    Total doses of intraoperative Epidural infusion (lidocaine 2%+epinephrine) and doses per hour

  7. Time for awakening in seconds [ Time Frame: Intraoperative ]
    Time for awakening (eyes opening) at the end of the surgery. Elapsed time in seconds between stopping the gas and opening the eyes of the patient

  8. Time for extubation in seconds [ Time Frame: Intraoperative ]
    Time for extubation in seconds. Elapsed time in seconds between stopping the gas and patient's extubation

  9. Time for transfert to the PACU in seconds [ Time Frame: Intraoperative ]
    Time for transfert to the PACU (Post Anesthesia Care Unit) in seconds, after extubatiuon

  10. First NRS pain score (0-10 scale) at times of awakening [ Time Frame: Intraoperative ]
    NRS (Numeric Rating Scale) Pain Score evaluated at times of awakening, evaluation from 0 (no pain) to 10 (worst imaginable pain) scale

  11. First NRS pain score (0-10 scale) at arrival in PACU [ Time Frame: Postoperative, evaluated at arrival in PACU ]
    First NRS Pain Score evaluated at arrival in PACU, evaluation from 0 (no pain) to 10 (worst imaginable pain)

  12. NRS pain score (0-10 scale) at rest, in PACU [ Time Frame: Postoperative, evaluated every 15 minutes until time for PACU discharge ]
    NRS Pain Score at rest, evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)

  13. NRS pain score (0-10 scale) with cough, in PACU [ Time Frame: Postoperative, evaluated every 15 minutes until time for PACU discharge ]
    NRS Pain Score with cough, evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)

  14. NRS pain score (0-10 scale) on the Shoulder, in PACU [ Time Frame: Postoperative, evaluated every 15 minutes until time for PACU discharge ]
    NRS Pain Score on the Shoulder, evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)

  15. Hydromorphone consumption (mg) in PACU [ Time Frame: Postoperative, evaluated every 15 minutes until time for PACU discharge ]
    Total cumulative dose of titration of intravenous hydromorphone (mg), evaluated every 15 minutes until time for readiness for PACU discharge

  16. PONV score (0-3 scale) in PACU [ Time Frame: Postoperative, evaluated every 15 minutes until time for PACU discharge ]
    PONV (PostOperative Nausea and Vomiting) score, evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 0 (no nausea) to 3 (nausea and vomiting)

  17. POSS score (1-4 scale) in PACU [ Time Frame: Postoperative, evaluated every 15 minutes until time for PACU discharge ]
    POSS (Pasero Opioid-induced Sedation Scale) score evaluated every 15 minutes until time for readiness for PACU discharge, evaluation from 1 (awake and alert) to 5 (asleep deeply)

  18. Respiratory depression number in PACU [ Time Frame: Postoperative, evaluated every 15 minutes until time for PACU discharge ]
    Respiratory depression number evaluated every 15 minutes until time for readiness for PACU discharge

  19. Blood pressure (mmHg) in PACU [ Time Frame: Postoperative, evaluated every 15 minutes until time for PACU discharge ]
    Blood pressure (TAS/TAD/TAM) in mmHg evaluated every 15 minutes until time for readiness for PACU discharge

  20. Time for PACU discharge based on Aldrete scores (0-10 scale), in PACU [ Time Frame: Postoperative, evaluated every 15 minutes until time for PACU discharge ]
    Time for readiness for PACU discharge based on Aldrete scores (0-10), Aldrete score must be ≥ 9 for PACU discharge

  21. NRS pain score (0-10 scale) at rest, evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    NRS Pain Score at rest, evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)

  22. NRS pain score (0-10 scale) with cough, evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    NRS Pain Score with cough, evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)

  23. NRS pain score (0-10 scale) on the Shoulder, evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    NRS Pain Score on the Shoulder, evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (no pain) to 10 (worst imaginable pain)

  24. Hydromorphone consumption (mg), evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    Total cumulative dose of titration of intravenous hydromorphone (mg), evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge

  25. Epidural consumption (mg), evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    Total cumulative dose of titration of epidural (mg), evaluated every day, from 24 hours postoperative until the cessation of the PCEA (Patient Controlled Epidural Analgesia)

  26. PONV score (0-3 scale), evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    PONV (PostOperative Nausea and Vomiting) score, evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (no nausea) to 3 (nausea and vomiting)

  27. POSS score (1-4 scale), evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    POSS (Pasero Opioid-induced Sedation Scale) score evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 1 (awake and alert) to 5 (asleep deeply)

  28. Respiratory depression number, evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    Respiratory depression number evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge

  29. Blood pressure (mmHg), evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    Blood pressure (TAS/TAD/TAM) in mmHg evaluated every day, from 24 hours postoperative until time for readiness for hospital discharge

  30. Heart rate (bpm), evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    Heart rate (HR) in bpm (beats per minute), evaluated every day from 24 hours postoperative until time for readiness for hospital discharge

  31. Oxygen saturation (%), evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    Oxygen saturation (SPO2) in %, evaluated every day from 24 hours postoperative until time for readiness for hospital discharge

  32. Respiratory rate (bpm), evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    Respiratory rate (RR) in bpm (breaths per minute), evaluated every day from 24 hours postoperative until time for readiness for hospital discharge

  33. Temperature (°C), evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    Temperature (T°C), evaluated every day from 24 hours postoperative until time for readiness for hospital discharge

  34. Overall patient's satisfaction (0-100%), evaluated everyday from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    Overall patient's satisfaction, evaluated every day from 24 hours postoperative until time for readiness for hospital discharge, evaluation from 0 (unsatisfied) to 100% (fully satisfied)

  35. Quality of recovery (QoR-15), evaluated every day from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    Patients' perceived quality of recovery (QoR-15). This questionnaire includes 15 questions that are divided into 2 parts, part A contains the first 10 questions that are scored between 0 (never) and 10 (constantly), and part B contains the last 5 questions scored between 0 (constantly) and 10 (never). Evaluation test every day from 24 hours postoperative until time for readiness for hospital discharge

  36. 6-minutes walking score, evaluated every day from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    6-minutes walking score. The object of this test is to walk as far as possible for 6 minutes in the hospital hallway. Six minutes is a long time to walk after this surgery type, so it's important to practise 6 Minute Walk every day on a flat hard surface. Evaluation test every day from 24 hours postoperative until time for readiness for hospital discharge

  37. MOCA scores, evaluated every day from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]

    MOCA (Montreal Cognitive Assessment) scores test for Dementia, range from zero to 30, with a score of 26 and higher generally considered normal. In the initial study data establishing the MoCA, normal controls had an average score of 27.4, compared with 22.1 in people with mild cognitive impairment (MCI) and 16.2 in people with Alzheimer's disease.

    Evaluation test every day from 24 hours postoperative until time for readiness for hospital discharge


  38. Time for first walking/mobilization, evaluated every day from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    The time for first walking/mobilization, consist to determine the precise moment when the patient is able to get up from his bed, and sit on a chair, with and without help

  39. Time for first flatus, evaluated every day from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    Determine the time of first flatus which are a sign of recovery of lower GI function

  40. Time for return to food oral intake, evaluated every day from 24 hours postoperative to hospital [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    Patient is able to tolerate at least one solid meal without nausea, vomiting, bloating or worsening abdominal pain. Patient drinks liquids actively (ideally > 800-1000 ml/day) and do not require intravenous fluids infusion to maintain hydration

  41. Biological analysis, evaluated every day from 24 hours postoperative to hospital discharge [ Time Frame: Evaluated 24 hours postoperative, then everyday until hospital discharge, an average of 21 days ]
    Biological analysis, intraoperative and daily during the 21 postoperative days: serum electrolytes (Na+ Cl- Ca2+ Ca total Phophore, glycemia) creatinine, DFG, CRP, hemoglobin, white blood cell and platelet counts, serum albumin, INR, PTT

  42. Rate of hospital readmission and mortality postoperative [ Time Frame: Postoperative evaluation, up to 30 days following surgery ]
    Rate of hospital readmission and mortality postoperative up to 30 days following surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA status I, II or III
  • Patients older than 18 years
  • HIPEC for bowel surgery with oxaliplatin + dextrose 5% for a duration of 30 min
  • Duration and type of surgery requiring an epidural analgesia via an epidural catheter placed and tunnelled prior the general anesthesia induction and an arterial line placed after induction of general anesthesia.

Exclusion Criteria:

  • Any allergy to one drug used in our anesthesia or HIPEC protocol
  • Any contra-indication or patient's refusal for epidural placement
  • Chronic arrhythmic cardiac conditions
  • Chronic pain with use of opioids more than 3 times per week for 4 weeks
  • Bowel occlusion
  • Physical/mental incapacities
  • Unexpected difficult airway requesting excessive, possibly painful airway manipulations.
  • Epidural failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04104334


Contacts
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Contact: Philippe PR Richebé, MD PhD 514-743-6558 philippe.richebe@umontreal.ca
Contact: Moulay MI Idrissi, RC and RN 514-525-3400 ext 5762 moulay.idrissi@umontreal.ca

Locations
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Canada, Quebec
Hopital Maisonneuve Rosemont, CIUSSS de l'Est de l'Ile de Montréal Recruiting
Montréal-Est, Quebec, Canada, H1T 2M4
Contact: Nadia NG Godin, RC and RN    514-252-3400 ext 3193    ngodin.hmr@ssss.gouv.qc.ca   
Contact: Philippe PR Richebé, MD PhD    514-252-3400 ext 4620    philipperichebe@live.com   
Sponsors and Collaborators
Ciusss de L'Est de l'Île de Montréal
Investigators
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Principal Investigator: Philippe PR Richebé, MD PhD CIUSSS Est de l'île de Montréal
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Responsible Party: Philippe Richebe, MD, PhD, Professor, Director of Research, Department of Anesthesiology and Pain Medicine of Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal (CEMTL), Ciusss de L'Est de l'Île de Montréal
ClinicalTrials.gov Identifier: NCT04104334    
Other Study ID Numbers: 2019-1788
First Posted: September 26, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philippe Richebe, Ciusss de L'Est de l'Île de Montréal:
Cytoreduction
HIPEC
Oxaliplatin
Colorectal
Peritoneal
Carcinomatosis
Monitoring
Anesthesia
Additional relevant MeSH terms:
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Colorectal Neoplasms
Fever
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Body Temperature Changes
Remifentanil
Desflurane
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Inhalation
Anesthetics, General